The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.

Active Comparator: Optimal Medical Management (OMM)

Drug: Optimal Medical Management (OMM)

The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.

Detailed Description:

The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments:

SCS group (SCS+OMM)

OMM group

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

SCS candidate with the Specify 5-6-5 surgical lead

Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)

Average low back pain is ≥ 5 as assessed by the baseline NPRS

Average low back pain is greater than leg pain

Subject has persistent moderate to severe low back and leg pain despite other treatments

Exclusion Criteria:

Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01697358